One of the challenges upon application of pluripotent stem cells (typically iPS cells and ES cells) derived from humans or a mammal other than humans for regenerative therapy (typically transplantation therapy) is establishment of the technique that allows highly efficient production of the stem cells applicable to the therapy.
For example, pluripotent stem cells such as genomically unstable iPS cells are not suitable for in vivo transplantation, and thus genomically unstable pluripotent stem cells are required to be removed from a population of pluripotent stem cells of interest to obtain pluripotent stem cells such as iPS cells applicable to regenerative therapy. Upon removal of genomically unstable pluripotent stem cells, it is naturally required to evaluate the genomic stability of pluripotent stem cells.
However, methods for evaluation of genomic stability of pluripotent stem cells which have been reported so far (e.g. chromosome banding and fluorescence in situ hybridization (FISH)) require complicated procedures or proficient skills. Therefore, there is a need for a method that allows simple and highly efficient evaluation of genomic stability of pluripotent stem cells. Further, because many conventional evaluation methods require fixation of target cells, it has been difficult to directly evaluate genomic stability of pluripotent stem cells per se which are actually used for regenerative therapy (i.e. living cells).